A Comparison of Fidaxomicin and Oral Vancomycin for the Treatment of Clostridium Difficile Infection (CDI) in Hospitalized Patients Receiving Concomitant Antibiotics for the Treatment of Concurrent Systemic Infections
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Clinical Cure: Resolution of Diarrhea
研究概览
简要总结
Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure in the treatment of CDI, as well as for recurrence of CDI. Recent data suggested that among patients receiving CA, fidaxomicin is superior to vancomycin. While these data are encouraging, many clinicians remain unclear on how to apply these data to patient care. Additionally, patients were excluded from the trials presented to the FDA if it was expected that they would require ≥ 7 days of CA. Therefore, the clinical question still remains of how to apply these data to the real world patient who requires a long course of CA and develops CDI while on therapy. We therefore propose an open label, comparative and prospective study of fidaxomicin 200 mg twice daily vs oral vancomycin 125 mg four times daily for the treatment of CDI among patients who are receiving a long course of CA.
We hypothesize that fidaxomicin will be superior to vancomycin with respect to clinical cure for patients with CDI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older with >3 unformed stools/24 hours with positive stool test for C. difficile.
- •Patients receiving ≥ 1 high or medium risk antibiotic for treatment of an infection other than CDI, for an anticipated duration of ≥ 5 days from the time of enrollment.
- •High risk: carbapenems, 2nd-4th generation cephalosporins, fluoroquinolones, clindamycin, and beta-lactam/beta-lactamase inhibitor combinations
- •Medium risk: 1st generation cephalosporin, macrolides*, and aztreonam
- •*The macrolide would be considered to be low risk if patients are receiving intermittent macrolides for prophylaxis only and not for treatment of an acute infection
排除标准
- •Patients with severe-complicated disease that would compromise oral therapy (hypotenstion or shock, ileus or bowel obstruction, megacolon).
- •Patients with an allergy to oral vancomycin or fidaxomicin.
- •Patients anticipated to receive metronidazole after enrollment.
- •Patients who already received oral vancomycin or metronidazole (either oral or intravenous) for > 24 hours within the preceding 72 hours at the time of enrollment.
- •Patients anticipated to receive adjunctive C. difficile therapy (rifaxamin, nitazoxanide, tigecycline) after enrollment.
- •Patients who are on laxatives before they are enrolled into the study, such as lactulose, if:
- •Patients have had a recent dose adjustment;
- •Baseline number of bowel movement while on laxatives is unknown.
- •Number of bowel movements and/or consistency has not changed from baseline.
- •Patients who have had colostomy or ileostomy
- •Patients who will have colostomy or ileostomy after enrollment and before study ends
- •Patients who are or will be on long-term (>12 weeks) medium or high-risk antibiotics prophylaxis after enrollment
研究组 & 干预措施
Fidaxomicin
Fidaxomicin 200 mg PO BID for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
干预措施: Fidaxomicin (Drug)
Vancomycin
Vancomycin 125 mg PO QID for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
干预措施: Vancomycin (Drug)
结局指标
主要结局
Clinical Cure: Resolution of Diarrhea
时间窗: length of treatment plus 2 days, from a minimum of 12 to a maximum of 86 days
Resolution of diarrhea defined as ≤ 3 unformed stools for 2 consecutive days maintained until the end of therapy and for 2 days afterwards. The treatment course was at least 10 days, but it could be extended to a maximum of 12 weeks.
次要结局
- Recurrence of CDI(30 days after treatment's end (maximum of 114 days))
- 30-day Mortality(40 to 114 days)
研究者
Krishna Rao
Assistant Professor of Internal Medicine
University of Michigan